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Brain Activity Study for Cognitive Impairment in Parkinson's Disease
N/A
Recruiting
Led By Sarah Bick, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 40
Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Awards & highlights
Study Summary
This trial will study the brain activity of people with Parkinson's disease in order to better understand the cognitive impairments associated with the condition.
Who is the study for?
This trial is for English-speaking Parkinson's disease patients over 40, who are scheduled for deep brain stimulation surgery at Vanderbilt University Medical Center. Participants must be able to undergo intraoperative testing and have a clinical electrode trajectory that contacts the caudate.Check my eligibility
What is being tested?
The study aims to understand cognitive impairment in Parkinson's by recording brain activity from corticostriatal structures during deep brain stimulation surgery. It will measure neural activity associated with nonmotor symptoms of the disease.See study design
What are the potential side effects?
Since this trial involves neurophysiology recordings and neural stimulation during surgery, potential side effects may include typical surgical risks like infection or bleeding, as well as any specific reactions related to deep brain stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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I am scheduled for deep brain stimulation surgery at Vanderbilt under local anesthesia.
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I have been diagnosed with Parkinson's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in caudate DLPFC beta coherence
Nerve Block
Secondary outcome measures
Change in beta power with neural stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neural recordings and stimulationExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,118 Total Patients Enrolled
Sarah Bick, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to follow instructions or directions during surgery.The planned electrode path will touch the caudate.I am under 40 years old.I am 40 years old or older.I am scheduled for deep brain stimulation surgery at Vanderbilt under local anesthesia.I have a movement disorder that is not Parkinson's disease.I can undergo tests during surgery.I have been diagnosed with Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Neural recordings and stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects have enrolled in this research program?
"Confirmed. According to the clinical trials database, this medical experiment is presently seeking volunteers; it was initially published on June 2nd 2021 and updated on June 30th 2022. The trial necessitates 75 participants across one location."
Answered by AI
Is this trial accepting participants at the present time?
"Evidence on clinicaltrials.gov reveals that this research project is actively seeking participants, which was first published in June 2nd 2021 and most recently revised at the end of June 2022."
Answered by AI
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